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HRS

Plate, Fixation, Bone

产品代码
HRS
器械名称
Plate, Fixation, Bone
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 888.3030
FDA 专业组
Orthopedic
上市路径
需提交 510(k) 上市前通告
标记
属植入器械
该代码近三年的 510(k)
161 件
其中 Summary 已存档
147 份，可直接下载
FDA 历史累计 510(k)
1323 件（全部年份；本站只收录近三年的明细）

该代码近三年的 510(k)（161 件）

数据窗口为最近三年。最新一件：2026-08-28。

510(k) 号批准日期申请人器械名称摘要
K2618302026-08-28Ortler Global Tibbi Gerecler Anonim SiFRAXION 3.5 Plate System (Various - See Catalog);FRAPDF
K2625372026-08-19GM Dos Reis Industria e Comercio Ltda.Versalock Sterile Plating SystemPDF
K2602772026-08-13Mikron Makina San. ve Tic. Ltd. Sti.MIKRON TRAUMA BONE PLATE& SCREW SYSTEMPDF
K2615112026-07-28Newclip TechnicsXpert AnklePDF
K2614062026-07-21GM Dos Reis Industria e Comercio Ltda.Versalock Proximal Tibial Plating SystemPDF
K2620322026-07-16TriMed, Inc.TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TPDF
K2611912026-07-08Newclip TechnicsAlians Elbow SPDF
K2610542026-07-01Stryker Leibinger GmbH & Co KGRibPlate SystemPDF
K2613512026-06-26Bonebridge AGSALGINA 2.5mm Distal Radius SystemPDF
K2609582026-06-16I.T.S. GmbHI.T.S. Clavicle Plates with Angular Stability; I.T.SFDA
K2612072026-06-12Tyber Medical, LLCExalta Proximal Tibia Plating SystemPDF
K2607612026-06-05Medartis AGAPTUS Clavicle System 2.8PDF
K2610022026-06-02Biomet MicrofixationPectus Blu SystemPDF
K2610382026-05-29Newclip TechnicsXpert PFPPDF
K2611452026-05-09Avanti Orthopaedics, LLCAvanti Distal Elbow ORIF SystemPDF
K2603232026-04-30OrthoPediatrics Corp.OrthoPediatrics® Locking Cannulated Blade Plate SystPDF
K2600542026-04-24I.T.S. GmbHI.T.S. PRS Phoenix IIPDF
K2602282026-04-24Bonebridge AGPOYA 3.5mm Medial Proximal Tibia SystemPDF
K2604112026-04-24Chest Wall Innovations, Inc.PC Fix SystemPDF
K2600902026-04-10Actis Medical Pty., Ltd.SMART Osteotomy SystemPDF
K2537182026-04-01Nvision Biomedical Technologies, Inc.enHAnce PEEK Bunion SystemPDF
K2602742026-03-25Novastep SASAirlock® Ankle Plating SystemPDF
K2602912026-03-25Nvision Biomedical Technologies, Inc.Vortex5 Tailor's Bunion Correction SystemPDF
K2542532026-03-24Aap Implantate AGLOQTEQ® VA Proximal Humerus Plate 3.5PDF
K2542882026-03-23Skeletal Dynamics, Inc.Clavicle Fixation SystemPDF
K2604482026-03-19L&K BIOMED Co., Ltd.CastleLoc Pectus Bar SystemPDF
K2540532026-03-17A Plus Biotechnology Co., Ltd.APS Spear Locking PlatePDF
K2603902026-03-17GM Dos Reis Industria e Comercio Ltda.Super Upper Limbs Versalock Plating SystemPDF
K2539162026-03-16Medartis AGAPTUS Shoulder Proximal Humerus System, PentaLock 3.PDF
K2539062026-03-11Newclip TechnicsXpert HandFDA
K2540932026-03-10Synthes GmbHDePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating PDF
K2600692026-03-09Synthes GmbHDePuy Synthes VOLT™ Proximal Tibia 3.5 Plating SystePDF
K2603532026-03-03Arthrex, Inc.Arthrex Humeral Plating System (Anatomic Humeral PlaPDF
K2540542026-03-02Synthes GmbHVOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ CalPDF
K2542492026-02-27Hankil Tech Medical Co., Ltd.HKT Anatomical Locking Trauma SystemPDF
K2521662026-02-26Globus Medical, Inc.RIB LINK™ Fixation SystemPDF
K2536602026-02-20KLS-Martin L.P.KLS Martin Pure Pectus SystemPDF
K2541622026-02-20KLS Martin L.P.KLS Martin Ixos SystemPDF
K2517322026-02-12Met One Technologies, LLCWrist Fracture SystemPDF
K2537132026-01-21Arthrex, Inc.Arthrex Variable Angle (VA) Proximal Tibia Plating SPDF
K2540022026-01-15TriMed, Inc.TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed VoPDF
K2528072026-01-12Arthrex, Inc.Arthrex Anatomic Lapidus Plates and I-Beam Lapidus PPDF
K2531782026-01-06Crossroads Extremity SystemsTRILEAP Plating SystemPDF
K2510502025-12-19Gm Dos Reis Industria E ComercioPectus Versa SystemPDF
K2521912025-12-17Bonebridge AGBRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal PDF
K2528972025-12-11A Plus Biotechnology Co., Ltd.APS Osteotomy Fixation System (0945-1302-xx /4.5mm CPDF
K2509882025-12-11KLS-Martin L.P.KLS Martin Pure Pectus SystemPDF
K2529972025-12-11Hyperflex MedicalHyperFlex® Bunion Correction SystemPDF
K2526612025-11-19Fusion Innovations, LLCSternaFuse Ti Fixation SystemPDF
K2534232025-11-18Nvision Biomedical Technologies, Inc.ToeJack MIS Bunion SystemPDF
K2508652025-11-14KLS-Martin L.P.KLS Martin IPS Forearm SystemPDF
K2529492025-11-13Skeletal Dynamics, Inc.Geminus Volar Distal Radius Plating SystemPDF
K2529592025-11-12Intrauma S.P.AWRISTAR MultiAx Distal Radius KitFDA
K2533002025-10-28Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2526002025-10-09OrthoPediatrics Corp.Pediatric Plating Platform I Small-MiniPDF
K2518922025-09-08Maxxos Medical GmbHMAXXOS P.A.C.E. Foot & Ankle Plating SystemPDF
K2523562025-08-21Acumed, LLCThe Acumed Wrist Fixation System - 2.4mm ScrewsPDF
K2509232025-08-21Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2511352025-08-21Treace Medical ConceptsTreace Medical Concepts (TMC) Implant Fixation SystePDF
K2520612025-08-20TriMed, Inc.Distal Xtremities SystemPDF
K2511612025-08-18Globus Medical, Inc.ANTHEM® Fracture SystemPDF
K2519132025-08-16OsteoCentric TechnologiesOsteoCentric® UnifiMI® TCS Plating SystemPDF
K2506202025-08-15KLS Martin L.P.KLS Martin Ixos SystemPDF
K2513612025-07-30Tyber Medical, LLCTyber Medical Distal Radius Plating SystemPDF
K2516202025-07-25Zimmer BiometA.L.P.S. Proximal Humerus Plating SystemPDF
K2509522025-07-18Paragon 28, Inc.Baby Gorilla®/Gorilla® Plating SystemPDF
K2511322025-07-14Acumed, LLCThe Acumed Wrist Fixation System - Plates; The AcumePDF
K2519452025-07-10TriMed, Inc.TriMed Total Wrist Fusion System (Total Wrist FusionPDF
K2429882025-06-27Genostis AFGenostis Osteosynthesis SystemPDF
K2509292025-06-26TriMed, Inc.TriMed Ulnar Osteotomy System (Ulnar Osteotomy ComprPDF
K2432752025-06-26Exactech, Inc.Equinoxe® Scapula Fracture SystemFDA
K2512962025-06-18Acumed, LLCThe Acumed Wrist Fixation SystemFDA
K2509332025-06-11Bonebridge AGLORRAINE 2.5/3.5mm Distal Humerus SystemPDF
K2433682025-06-04Medifield Medical Co., Ltd.Montblanc Plate SystemPDF
K2427512025-05-30Jeil Medical CorporationARIX Pectus Bar SystemPDF
K2434692025-05-29Osteonic Co., Ltd.SIGNEXPDF
K2509352025-05-22TriMed, Inc.TriMed Fifth Metatarsal System (Fifth Metatarsal PlaPDF
K2439632025-04-29OrthoPediatrics Corp.Pediatric Plating Platform HipPDF
K2508922025-04-25L&K BIOMED Co., Ltd.CastleLoc Pectus Bar SystemFDA
K2429732025-04-24Canwell Medical Co., Ltd.CanMINI Hand and Foot SystemFDA
K2501552025-04-23Newclip TechnicsXpert KneePDF
K2509482025-04-08TriMed, Inc.TriMed Fusion Cup SystemPDF
K2439952025-03-26Arthrex, Inc.Arthrex Humeral Plating System and Cerclage ButtonPDF
K2439872025-03-19TriMed, Inc.TriMed Elbow and Forearm SystemPDF
K2424862025-03-19Tyber Medical, LLCTyber Medical Anatomical Plating SystemPDF
K2439992025-03-19TriMed, Inc.TriMed Ankle Fixation SystemPDF
K2504942025-03-18OsteoCentric TechnologiesThe OsteoCentric Bone Plate and Screw SystemPDF
K2504982025-03-17Orthonovis, Inc.BPS Wrist Fracture SystemPDF
K2436102025-03-07Medartis AGAPTUS Hand System; APTUS Elbow Dorsal OlecranonPDF
K2433572025-02-27L&K BIOMED Co., Ltd.CastleLoc Pectus Bar SystemPDF
K2416662025-02-19Smith & NephewEVOS Pelvic and Acetabular SystemPDF
K2437612025-02-19Biomet OrthopedicsA.L.P.S. Small Fragment Plating SystemPDF
K2409582025-02-10Hebei Ruihe Medical Devices Co., Ltd.Locking Plates and Screws SystemsPDF
K2500552025-02-06Orthonovis, Inc.BPS - Bone Fragment Fixation Plates, Screws and WashPDF
K2415992025-02-06Signature Orthopaedic Pty , Ltd.Signature Osteosynthesis Plate SystemPDF
K2437402025-01-29GM Dos Reis Industria e Comercio Ltda.Versalock Upper Limb Plating SystemFDA
K2435692025-01-15TriMed, Inc.TriMed Wrist Fixation System (Volar Bearing Plates);PDF
K2429392024-12-23Artfx MedicalARTFX Trauma Bone Plate and Screw SystemPDF
K2433082024-12-20Bonebridge AGBonebridge Osteosynthesis Plating System (SALGINA 2.FDA
K2434912024-12-11Stryker Leibinger GmbH & Co KGSternalPlate ExpansionPDF
K2411282024-12-05Tdm Co., Ltd.TDM Plate and Screw SystemPDF
K2430502024-11-26TriMed, Inc.TriMed Posterior Malleolus Fixation SystemPDF
K2419952024-11-26Footbridge MedicalHyperFlex™ Bunion Correction SystemPDF
K2429982024-11-21GM Dos Reis Industria e Comercio Ltda.GMReis Ankle Plating SystemPDF
K2425962024-11-21GM Dos Reis Industria e Comercio Ltda.Versalock Mini and Micro Plating SystemPDF
K2420792024-11-14Arthrex, Inc.Arthrex Elbow Fracture Plating SystemPDF
K2424362024-11-14Skeletal Dynamics, Inc.Proximal Humerus Fixation SystemPDF
K2428142024-11-14Microware Precision Co., Ltd.Tandry Q-Locking Plate SystemFDA
K2403882024-11-014Web Medical, Inc.Osteotomy Truss System (OTS)PDF
K2423992024-10-31Bonebridge AGBonebridge Osteosynthesis Plating SystemPDF
K2429952024-10-23The Orthopaedic Implant CompanyOIC Small / Mini Fragment Plate SystemPDF
K2425542024-10-21Arthrex, Inc.Arthrex VAL and VAL KreuLock™ Compression Screw SystPDF
K2401812024-10-09Auxein Medical Pvt., Ltd.Clavicle and Scapula SystemPDF
K2424452024-10-06Stryker GmbHPangea Platform; Pangea Femur Plating System; PangeaPDF
K2423432024-10-04Orthonovis, Inc.BPS Wrist Fracture SystemPDF
K2418152024-09-26Skeletal Dynamics, Inc.Protean Fragment Plating SystemFDA
K2417092024-09-19Biomet MicrofixationPectus Blu Support Bar SystemFDA
K2419422024-09-17TriMed, Inc.TriMed Bridge PlatesPDF
K2413562024-09-05Bodycad Laboratories, Inc.Fine Osteotomy™PDF
K2404872024-09-03Smith & NephewEVOS Patella PlatesPDF

其中 147 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。

另有 41 件未列出。

FDA 官方分类页： HRS
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。